FDA Inspection
Cardiomedix IncorporatedCardiomedix Incorporated – FDA Inspection, Jul 16, 2021
Record Details
This FDA Inspection record concerns Cardiomedix Incorporated, with an inspection on July 16, 2021, issued by the Center for Devices and Radiological Health, covering devices.
- Company
- Cardiomedix Incorporated
- Inspection Date
- July 16, 2021
- Product Type
- Devices
View Company Profile
ID · a77494c7-b070-42cc-b094-35c3a4c4b19f
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 1146286
- FDA center
- Medical Devices & Rad Health
- Project area
- Compliance: Devices
FDA Citations
6- 21 CFR 820.20(d)Quality plan
- 21 CFR 820.20(b)(3)Management representative
- 21 CFR 820.20(c)Management review - Lack of or inadequate procedures
- 21 CFR 820.198(a)Lack of or inadequate complaint procedures
- 21 CFR 820.20(a)Quality policy and objectives
- 21 CFR 820.50(a)(2)Supplier oversight
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